Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GC1008 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Dose Group |
| Cohort B | EXPERIMENTAL | Dose Group |
| Cohort C | EXPERIMENTAL | Dose Group |
| Cohort D | EXPERIMENTAL | Dose Group |
| Cohort 1 | EXPERIMENTAL | Dose group |
| Cohort 2 | EXPERIMENTAL | Dose Group |
| Cohort 3 | EXPERIMENTAL | Dose Group |
| Cohort 4 | EXPERIMENTAL | Dose Group |
| Cohort 5 | EXPERIMENTAL | Dose Group |
| Name | Type | Description |
|---|---|---|
| GC1008 | BIOLOGICAL | 1 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days. |
Inclusion Criteria: * GFR≥25ml/min/1.73m2 calculated by the MDRD equation * Urinary total protein: creatinine ratios \>200mg/mmol derived from the average of 2 first morning voids taken during screening period * Biopsy confirmed as idiopathic FSGS by a central reviewer * Treatment resistance. NOTE:...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | frexalimab, brivekimig, rilzabrutinib |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| Akebia Therapeutics, Inc. | AKBA | 1 | PHASE2 | Praliciguat |
| Travere Therapeutics, Inc. | TVTX | 1 | PHASE2 | Sparsentan |
| Vera Therapeutics, Inc. Class A | VERA | 1 | PHASE2 | Atacicept |
GC1008 is an investigational monoclonal antibody being studied for Focal Segmental Glomerulosclerosis (FSGS) and Idiopathic Pulmonary Fibrosis (IPF). It is being developed by Sanofi (SNY) and is currently in Phase 1 clinical development.
GC1008 is being developed by Sanofi, which trades under the ticker SNY. The drug is an investigational monoclonal antibody in Phase 1 clinical development for Focal Segmental Glomerulosclerosis and Idiopathic Pulmonary Fibrosis.
GC1008 is in Phase 1 clinical development. It is an investigational monoclonal antibody studied in completed Phase 1 trials for Focal Segmental Glomerulosclerosis and Idiopathic Pulmonary Fibrosis. It has not been approved by regulatory authorities.
GC1008 has been studied in two completed Phase 1 trials. NCT00125385 evaluated GC1008 in patients with Idiopathic Pulmonary Fibrosis, enrolling 25 participants in the United States and Belgium. NCT00464321 evaluated single doses in patients with treatment-resistant Focal Segmental Glomerulosclerosis, enrolling 16 participants across the United States, Germany, Italy, and the United Kingdom.
GC1008 is the drug name used in clinical trials for this investigational monoclonal antibody. It is being developed by Sanofi for Focal Segmental Glomerulosclerosis and Idiopathic Pulmonary Fibrosis, and no alternative names have been established in the public record.